Chemical Residue Violations: Are You Doing Enough To Prevent Them?
By Jane Johnson, DVM
On April 25, 2012, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) published a notice in the Federal Register announcing the availability of a compliance guide for the prevention of chemical residue violations in animals at slaughter plants. The guidance document, Compliance Guide For Residue Prevention 2012, is available for review on FSIS’ Web site at www.fsis.usda.gov/PDF/Residue_Prevention_Compliance_Guide_042512.pdf..

As a small or very small plant owner or operator, you may already know that FSIS oversees the U.S. National Residue Program. The purpose of this program is to protect the consumer from domestic and imported meat, poultry, and processed egg products that are adulterated because of illegal chemical residues. The Agency collects samples of meat, poultry, and processed egg products at federally inspected plants and analyzes them at FSIS laboratories for chemical residues of veterinary drugs, pesticides, and environmental contaminants such as toxins from fungi and heavy metals like lead and arsenic.

Another important component of the National Residue Program is to have plants provide verification of residue control in Hazard Analysis and Critical Control Points (HACCP) systems. As part of the HACCP regulation under Title 9 of the Code of Federal Regulations, Part 417 (9 CFR Part 417), you’re required to conduct a hazard analysis and to consider the food safety hazards that can be expected to arise from drug and other chemical residues. You’re also required to maintain documentation that supports the
decisions made in your hazard analysis as a part of your records.

FSIS expects, as it has since HACCP was implemented, that you will verify the ongoing effectiveness of your residue programs under HACCP. If you determine in your hazard analysis that the food safety hazard “drug residues” is not a hazard reasonably likely to occur, then you are required to reassess your HACCP plan each time a drug residue violation is found by FSIS. Of course, it will be difficult for you to support the decision that drug residues are not reasonably likely to occur if FSIS finds repeated violations.

FSIS’ guidance document emphasizes five steps you can take to help prevent the occurrence of residue violations in
livestock or poultry at your plant:

Confirm producer history
You should have effective residue control programs that include measures that take into account the historical residue violation information associated with producers. A livestock producer is the individual, farm, dairy, ranch, feed yard, or other firm from which the animal originates. You can access the Residue Repeat Violator List for Use by Livestock Markets and Establishments at www.fsis.usda.gov/PDF/Residue_EST.pdf to obtain the list of repeat violator producers prior to purchasing
the animals. The list includes only producers who have supplied more than one animal with an illegal residue level in the past year.

The Residue Repeat Violator List for Use by Livestock Markets and Establishments is updated weekly. Since the list identifies livestock from known producers of repeat violator animals, it can be a valuable tool for assisting you in avoiding illegal residues in animals you slaughter. One way to protect yourself is to require a letter or certification from the seller, livestock market, or auction on a lot-by-lot basis demonstrating that the person issuing the letter or certification has reviewed
the most recently posted Residue Repeat Violator List for Use by Livestock Markets and Establishments and determined that none of the animals in the lot came from suppliers with more than one violation in the last 12 months.

In addition, if you regularly purchase livestock from a market, instead of getting a certification for each lot, you may decide to obtain a general certification that the market will check the list for each lot, although you should regularly ensure that the market is adhering to this certification. This documentation may also identify those animals from a producer known to be on the Residue Repeat Violator List.

If you don’t use the information in the Residue Repeat Violator List, either directly or through a letter or certification, you’re not taking advantage of a tool to identify livestock from known repeat violators. Thus, you would not be taking advantage of a means of controlling a hazard that’s foreseeable.

Buy residue-free animalsBuy animals from producers that have a history of providing residue-free animals, that employ an effective residue prevention program, and that use drugs judiciously by avoiding unnecessary or inappropriate use. In addition, require documentation from the producer that the animals are “Drug Residue Free.” The U.S. Department of Health and Human Services’ Food and Drug Administration (FDA) recommends in its guidance on the judicious use of medically important drugs that producers limit use in food-producing animals of medically important antimicrobial drugs to cases when such use is necessary to ensure animal health, and then only with veterinary oversight or consultation.

Ensure animals are adequately identified
FSIS encourages you to purchase animals with sufficient identification, such as ear tags or back tags, to trace back to the producer and not to purchase any livestock that do not have identification that would allow them to be traced back to the farm of their origin. Livestock should be consistently identified with ear tags or back tags, and that identification has to be maintained with the livestock through the slaughter process until post-mortem inspection is complete. Maintaining proper
identification of livestock enables accurate trace back to the producer that can be upheld in a court of law if necessary.

Without adequate identification, neither you nor FSIS can utilize herd history to assess how likely livestock are to have violative levels of chemicals. Livestock that do not have animal identification may have had the identification intentionally removed in an effort to obscure their origin, leading to an FSIS concern about a higher risk that these animals contain violative residues.

Given this risk and the facts supporting it, FSIS inspection personnel will be less likely to test livestock presented for ante-mortem inspection that are properly identified with respect to the producer, or for which the plant has an appropriate certification from the seller, livestock market, or auction. When livestock are not identified at ante-mortem inspection, given the
Agency’s experience with such livestock, FSIS is likely to test such animals at a more frequent basis (up to 100 percent).

Supply the producer information to FSIS at antemortem inspection
When producer information or other assurances are not available at ante-mortem, or when the livestock are purchased from a producer listed on the Residue Repeat Violator List for Use by Livestock Markets and Establishments, FSIS is likely to screen test the livestock at a higher rate and may test up to 100 percent.

FSIS is likely to screen test the livestock at a lower rate if it is presented with producer information or a letter or certification from the seller, livestock market, or auction, on a lot-by-lot or other appropriate basis, demonstrating that the person issuing the letter or certification reviewed the most recently posted Residue Repeat Violator List for Use by Livestock Markets and
Establishments and determined that none of the animals in the lot came from suppliers with more than one violation inn the last 12 months.

Notify Producers of Violative Animals
Slaughter plants are notified through FSIS’ Public Health Information System (PHIS) of both violative residues and of residues that are detectable but that do not exceed the tolerance levels established by FDA and the U.S. Environmental Protection Agency. You should notify animal producers in writing if their animals are found with either violative or non-violative levels of a drug residue. Persistent non-violative residues may indicate a pattern of usage that could result in violations
at some point. Such notification should include a discussion of the issues involved, the company’s future expectations, and an indication that repeat violators will not be future suppliers.

FSIS accepted comments on the Compliance Guide for Residue Prevention 2012 through June 25, 2012. The guide
will be updated as needed in response to those comments. However, FSIS encourages you to start following the recommendations it contains now, especially if you slaughter dairy cows and bob veal calves.

For more information or questions on chemical residues and chemical residue prevention, you may wish to contact the Small Plant Help Desk at 1-877-FSISHELP (1-877-374-7435) or InfoSource@fsis.usda.gov.

FSIS Launches the New Label Submission and Approval SystemBy Jane Johnson, DVM FSIS’ Labeling and Program Delivery Division (LPDD) has launched the Label Submission and Approval System (LSAS). The LSAS is a secure Web-based system that can be used for submitting label applications to LPDD, giving you, the small or very small plant owner/operator, an alternative to the current method of submitting paper applications by mail, express mail, courier, or fax. Paper label application submissions will still be accepted.

This system’s launch will have a significant impact on the speed and accuracy of label review, as well as the ability to develop data-specific reports based on labeling information.

While the system will not check labels automatically for errors, it will scan for some common errors in the label submission process, including illegible labels, missing information on the transmittal form, and missing supporting documentation. This will help to improve the label submission process. The system will also include a feature that will help submitters determine whether a label can be
generically approved or if it must be submitted to FSIS for approval.

To use the system, users will need to have USDA “Level 2” e-Authentication (eAuth). Below are the steps to create an account:

Log onto www.eauth.egov.usda.gov, and complete the online application for approval. USDA will notify you when your account is approved.

After you receive your notification of approval, you’re required to have a Licensed Registration Agent (LRA) verify your identity in person. You must do this before you can receive a password for your eAuth account. Find an agent in your area using the map provided by eAuth at www.eauth.egov.usda.gov and click on the “Find an LRA” button at the top right corner of the page.

Commonly Asked Questions & AnswersQ.If an official establishment purchases meat and poultry products from another federally inspected establishment and then repackages such products (e.g., product that is received in bulk and repackaged into consumer-size packages), can the labels applied to the re-packaged product be generically approved from the purchased product label?

A. No. The fact that the product is purchased from another establishment has no bearing on whether the label applied by the second establishment can be generically approved. However, if the product is a single ingredient and bears no special claims, guarantees or foreign language, it is a generically approved label under 9 CFR 317.5(b)(2) or 381.133(b)(2). Additionally, if the product is a
multi-ingredient standardized product, that is, it has a standard of identity or composition in 9 CFR 319 or 381 Subpart P or the Food Standards and Labeling Policy Book, and the labeling bears no special claims, guarantees, or foreign language, it qualifies as a generically approved label under the regulation citation provided above.